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510(k) K031772

TI FENESTRATED PLATE by Interpore Cross Intl. — Product Code KWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2003
Date Received
June 9, 2003
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

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  • K040928 — EXPANDABLE PEEK VBR IMPLANT (August 27, 2004)
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  • K033961 — ALTIUS OCT SYSTEM (April 14, 2004)
  • K040168 — MODIFICATION TO GEO STRUCTURE (April 8, 2004)

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